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Trial record 60 of 152 for:    severe preeclampsia AND Pregnancy Complications

Association Between Pococyturia and Pre-eclampsia Severity (PEPOD2)

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ClinicalTrials.gov Identifier: NCT03316391
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Twenty four hours proteinuria is a key element to define pre-eclampsia severity but is delaying the result by 24 hours and constraining for the patient. A simple and rapid indicator for severe preeclampsia would help clinicians to make appropriate decision in patient management. We hypothesized that urinary podocyturia is correlated to preeclampsia severity. This is a prospective, non-interventional, monocentric study.

Condition or disease Intervention/treatment
Pre-Eclampsia Other: Dosage of urinary podocyturia

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Study : Association Between Pococyturia and Pre-eclampsia Severity
Actual Study Start Date : May 22, 2019
Estimated Primary Completion Date : March 22, 2025
Estimated Study Completion Date : March 22, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pre-eclampsia
Patients in hospital for pre-eclampsia at the Hopital Femme-Mère-Enfant
Other: Dosage of urinary podocyturia
Dosage of urinary podocyturia at admission, delivery and post-partum visit




Primary Outcome Measures :
  1. Severity of pre-eclampsia [ Time Frame: at childbirth (maximum 10 months) ]

    Severe preeclampsia is defined by preeclampsia with at least one of the following criteria :

    • severe hypertension (PAS ≥ 160 mmHg et/ou PAD ≥ 110 mmHg)
    • Renal impairment with: oliguria <500 ml / 24h or creatinine> 135 μmol / L or proteinuria> 5 g/d
    • acute lung edema or persistent epigastric bar or HELLP syndrome
    • eclampsia or rebellious neurological disorders (visual disturbances, polykinetic ROT, headache),
    • thrombocytopenia <100 G / L
    • Retro Placental Hematoma (HRP) or fetal repercussion.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in hospital for pre-eclampsia at the Hopital Femme-Mère-Enfant
Criteria

Inclusion Criteria:

  • women aged 18 years or more
  • single pregnancy
  • admission for pre-eclampsia
  • patient receiving information and non-opposition to participate

Exclusion Criteria:

  • multiple pregnancy
  • in utero fetal demise excepted if associated with pre-eclampsia
  • antecedent of nephropathy
  • fetal malformation, chromosomal anomalies
  • inability to understand information provided
  • prisoner or under administrative supervision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316391


Contacts
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Contact: Muriel DORET-DION, MD 04 27 85 51 70 ext +33 muriel.doret-dion@chu-lyon.fr

Locations
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France
Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France Recruiting
Bron, France, 69677
Contact: Muriel DORET-DION, MD    04 27 85 51 70 ext +33    muriel.doret-dion@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03316391     History of Changes
Other Study ID Numbers: 69HCL17_0517
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications